Approval of the patch comes as use of methylphenidate and other ADHD drugs increases in the United States. Nearly 3.3 million Americans age 19 and younger used an ADHD drug last year, according to Medco Health Solutions Inc., a prescription drug benefit program manager.

It is the same stimulant that is in Ritalin. The patch is made by Noven Pharmaceuticals Inc. of Miami, Florida.

For Use When Taking Pills Is Difficult

In December, an FDA panel of independent experts voted to recommend that the patch's label encourage its use as an alternative treatment for children ages 6 to 12 with ADHD, meaning doctors should prescribe it only if taking pills is too difficult for a child. ADHD is a condition in some children that makes concentration and learning difficult.

Unlike pill forms of the drug, the patch can be removed should it cause side effects.

Noven Pharmaceuticals submitted a 12-hour version of the patch to the FDA in 2003. The agency rejected it and recommended that Noven test a nine-hour version. That version was approved for use Thursday.

Shire Pharmaceuticals Group PLC, based in Britain, co-developed the patch with Noven Pharmaceuticals.

Risk of Stroke, Hallucinations

Approval of the patch comes as use of methylphenidate and other ADHD drugs increases in the United States. Nearly 3.3 million Americans age 19 and younger used an ADHD drug last year, according to Medco Health Solutions Inc., a prescription drug benefit program manager.

The FDA continues to grapple with whether to require more severe warnings on the labels of the drugs.

A panel of outside experts recently recommended to the FDA that the drugs bear labels that caution users in plain language about possible dangers, including stroke and hallucinations. Earlier, another FDA panel recommended that the medicines include so-called "black-box" warnings, the strongest warnings a prescription drug can bear.